May 30, 2013 (NOT-OD-13-074) -
NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.

August 16, 2010 - IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections
must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.

November 3, 2010 - See Notice NOT-HS-11-002 Special Emphasis Notice (SEN): AHRQ Announces Areas of Interest for Research on Healthcare-Associated Infections.

September 29, 2010 (NOT-OD-11-007) - NIH to Require Use of Updated Electronic Application Forms in 2011. Adobe B1 forms are required for due dates on or after May 8, 2011.

NOTICE: Applications submitted in response to this
Funding Opportunity Announcement (FOA) for Federal assistance must be submitted
electronically through Grants.gov (http://www.grants.gov)
using the SF424 Research and Related (R&R) forms and the SF424 (R&R)
Application Guide.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines
included with this announcement in Grants.gov/Apply
for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and applicants are
highly encouraged to start the process at least four weeks prior to the grant
submission date. See Section
IV.

Purpose. This Funding Opportunity Announcement (FOA) encourages
Small Research Grant (R03) applications, and expresses AHRQ portfolio
priority areas of interest for ongoing small research projects. The R03
grant mechanism supports different types of health services
research projects including pilot and feasibility studies; secondary
analysis of existing data; small, self-contained research projects;
development of research methodology; and, development of new research
technology.

Mechanism of Support. This FOA will use
the AHRQ Small Research Grant (R03) mechanism.

Funds Available and Anticipated Number of Awards. Because the nature and scope of the proposed
research will vary from application to application, it is anticipated that
the size and duration of each award will also vary. The total amount
awarded and the number of awards will depend upon the mechanism numbers,
quality, duration, and costs of the applications received.

Budget and Project Period. Atotal project period of up to two years and a budget
of up to $100,000 in total costs may be requested in an application
submitted in response to this FOA.

Application Research Strategy Length: The R03 Research Strategy section may not exceed 15 pages,
including tables, graphs, figures, diagrams, and charts.

Eligible Project Directors/Principal Investigators (PDs/PIs): Individuals with the skills, knowledge, and resources necessary to
carry out the proposed research are invited to work with their
institution/organization to develop an application for support.
Individuals from underrepresented racial and ethnic groups as well as
individuals with disabilities are always encouraged to apply for AHRQ
support.

Number of PDs/PIs: Only one PD/PI may
be designated on the application.

Number of Applications: Applicants may
submit more than one application, provided each application is
scientifically distinct.

Resubmissions: Applicants
may submit one resubmission application, but such applications must
include an Introduction addressing the previous peer review critique
(Summary Statement).

Hearing Impaired: Telecommunications
for the hearing impaired are available at: TTY 301-451-5936.

While grant awards are made to institutions rather than individuals,
this announcement and its instructions are written to inform individual
researchers of this funding opportunity and facilitate the submission of grant
applications by their organizations. The applicant will be solely responsible
for planning, directing, and executing the proposed project.

The mission of AHRQ is to improve the quality, safety,
efficiency, and effectiveness of health care for all Americans. AHRQ
strives to achieve its mission by supporting a wide range of health services
research projects. However, all R03 grant applications must contain projects
that fit within the current AHRQ Research Portfolio areas as described below:

Comparative
Effectiveness Portfolio

AHRQ intends to
support research grants focusing on comparative effectiveness, as authorized in
the Medicare Prescription Drug, Improvement, and Modernization Act (MMA)
Section 1013. Comparative effectiveness research is the conduct and synthesis
of research comparing the benefits and harms of different interventions and
strategies to prevent, diagnose, treat and monitor health conditions in “real
world” settings. The purpose of this research is to improve health outcomes by
developing and disseminating evidence-based information to patients,
clinicians, and other decision-makers, responding to their expressed needs,
about which interventions are most effective for which patients under specific
circumstances[1].

The intent of these
grants is to support research focusing on the generation and translation of new
scientific evidence and analytic tools in an accelerated format and the
integration of evidence into practice and decision-making in the health care
system. New applicants are encouraged to partner with institutions well versed
in systematic review methodologies or with research centers and integrated
health care delivery systems capable of performing accelerated clinical
effectiveness and outcomes research and the translation and dissemination of
evidentiary information for health care decision-making. Existing examples of
such AHRQ networks include, the Evidence-based Practice Centers (EPCs), the
Developing Evidence to Inform Decisions about Effectiveness (DEcIDE) network,
the Centers for Education & Research on Therapeutics (CERTs), the John M.
Eisenberg Clinical Decisions and Communications Science Center, Primary
Care-Based Research Network (PBRN), and the Accelerating Change and
Transformation in Organizations and Networks (ACTION). A listing of these
research networks under AHRQ’s Effective Health Care program can be found at: http://effectivehealthcare.ahrq.gov.

The grants can have
either a clinical or methodological emphasis, but must focus tightly on the
study and/or the use of comparative effectiveness research. For grants with
methodological emphasis, the goals should be to advance study designs and
methods to fill specific knowledge gaps and to enhance the consistency,
applicability, and generalizability of the comparative effectiveness studies.
For grants with clinical emphasis, the goals should be to develop new
scientific evidence that fills important knowledge gaps and to generate
critical insights on the clinical effectiveness and comparative clinical
effectiveness of health care interventions. Defined interventions compared may
include medications, procedures, medical and assistive devices and
technologies, diagnostic testing, behavioral change, and delivery system
strategies. For studies in which randomized controlled trails may not be
feasible or timely, or would raise ethical concerns that are difficult to
address, novel or alternative study designs may be proposed. Such clinical
research projects also need to be informed by the information needs and inputs
from various stakeholders (e.g., policy-makers, providers, and patients) to
ensure the most appropriate outcome measures for assessing the effectiveness of
the interventions and outcomes of importance to stakeholders are included in
the study. Research projects should also be organized around a set of priority
conditions of importance to the Medicare, Medicaid, and SCHIP programs as
mandated by the MMA section 1013. The current list of conditions includes:

AHRQ interests in R03
pilot and feasibility studies, or otherwise self-contained small methodological
and/or clinical comparative effectiveness research projects include, but are
not limited to:

Effectiveness/comparative effectiveness
of health care treatments, including pharmaceuticals, devices, and other types
of interventions or combinations of these interventions.

Studies of the effectiveness/comparative
effectiveness of important new or existing health care technologies.

Understanding of the cognitive
foundation, challenges, and potential sources of biases in the communication of
risk/benefit information and decision-making.

Development and evaluation of strategies
for incorporating evidence into decision-making for patients, providers, and
policymakers.

Conceptual frames for the identification,
role, and assessment of observational studies in the systematic review and
synthesis of evidences on comparative effectiveness and in various
decision-making contexts.

Study designs, analytical tools, and
statistical techniques for reducing confounding and to mitigate the impacts of
potential bias inherent in the observational studies of effectiveness and
comparativeness effectiveness.

Communication of risk and benefit and
contextual information that enhance the use of evidence in decision-making.

Emerging Issues and
Innovations Portfolio

The Innovations
Portfolio was created to identify and support researchers and institutions with
ideas that have the potential for high impact. These ideas will be novel and
span a diverse (and perhaps non traditional) array of disciplines. The
portfolio will foster and nurture ideas and projects that have the potential to
lead to highly innovative solutions that may lead to significant advances in
healthcare practice, organization, delivery, and management. Research and
activities supported under the Innovations Portfolio will reflect ideas
substantially different from those already being pursued elsewhere. The
portfolio will fund transformative research with a focus on projects that
transform existing conditions and that solve pressing healthcare problems. The
main focus of the portfolio is problem solving in order to accelerate
improvement in healthcare. Under the R03 mechanism applicants are encouraged
to submit pilot and feasibility studies, or otherwise self-contained small
methodological studies.

Health Information
Technology Portfolio

Health information
technology (IT)is broadly defined as the use of information and
communication technology in health care to support the delivery of patient or
population care or to support patient self-management. Health IT can support
patient care related activities such as order communications, results
reporting, care planning and clinical or health documentation. For current R03
grant funding opportunities in the area of health IT, applicants are advised to
see the Funding Opportunity Announcement PAR-08-268 (see https://grants.nih.gov/grants/guide/pa-files/PAR-08-268.html).

Patient Safety
Portfolio

Patient safety
research initiatives can be considered to occur in three different stages:

identification
of risks and hazards;

design,
implementation, and evaluation of patient safety practices; and

maintaining
vigilance to ensure that a safe environment continues and patient safety
cultures remain in place.

The Patient Safety
Portfolio will support research projects that seek to create new knowledge by
identifying the risks and hazards encountered by patients as a result of health
care. Proposals in this area may address important topics such as: the impact
of human performance and working conditions on patient safety; the role
consumers can play and how they can contribute to making care safer; health
care organizational structure, leadership, communication, and teamwork; health
care associated infections; diagnostic error; and the challenges inherent in
transitions of care and handoffs between health care providers.

AHRQ encourages an
interdisciplinary approach to research that is related to patient safety, so
that the perspectives not only from the field of health care services but also
from the social and behavioral sciences (such as organizational psychology)
education, industrial engineering, human factors, and others are incorporated
in such a way so that they contribute meaningfully to research plans.

The mission of the
Prevention/Care Management Portfolio is to improve the quality, safety,
efficiency, and effectiveness of evidence-based preventive services and chronic
care management in ambulatory care settings. We are interested in grants that
will support two broad strategic goals.

The first goal focuses
on preventive services. Grants awarded in this strategic area should
complement the work of the U.S. Preventive Services Task Force in terms of
advancing methods for assessing the benefits and harms of preventive services,
and improving the implementation of evidence-based recommendations on
preventive services. We are interested in funding areas that have not
traditionally been the focus of funding initiatives, such as:

Harms
associated with preventive services;

Overuse
of preventive services; and

Delivery
of preventive services for the patient with multiple co-morbidities.

Examples of grant
applications that would be considered under this strategic area include, but
are not limited to, research on the:

Effectiveness
of preventive services in improving health and quality of life in complex
patients;

Development
of new methodologies for assessing the harms of preventive services; and

Does
the implementation of individual USPSTF “A” and “B” recommended preventive
services or a set of recommended services actually improve overall health
outcomes in a particular geographic area or integrated health system or
priority population?

Our second goal
involves improving primary care and clinical outcomes through health care
redesign, clinical-community linkages, self management support, and care
coordination based on the Care Model (Wagner 1998; Barr, et. al.; 2002). We
are interested in moving beyond condition-specific research to support grants
that are focused on system redesign in ambulatory care, the results of which
would be generalizable across health conditions. Examples of grant
applications that would be considered under this strategic area include, but
are not limited to, research on the effectiveness, efficiency, and/or
implementation of:

New
models of delivering primary care with the potential to improve both preventive
services and chronic care management, including, but not limited to, the
patient-centered primary care medical home. Potential areas of interest
include:

Role
of clinical teams within the patient-centered, primary care medical home

Costs
and benefits of the patient-centered, primary care medical home to patients,
clinicians, practices and health systems;

Methods
of linking primary care practices with community resources to improve the
delivery of preventive services and care management;

AHRQ
seeks to support research to develop, disseminate, and translate rigorous
evidence that can be used by public and private policymakers, by health system
and community leaders, and by managers of healthcare organizations who want to
improve the delivery of healthcare services by reducing unnecessary costs
(waste) and increasing efficiency, while maintaining or improving healthcare
quality, i.e., increasing the value of health care for all Americans. In
addition to applications of systematic quantitative research methods,
qualitative and mixed-methods research are also encouraged. Research
priorities include:

Identifying ways to improve these
factors and identifying strategies and techniques for improving the delivery of
health care services -- including redesign of administrative and care processes
(e.g., Lean, reengineering, improvement collaboratives) and redesign
(reorganization) of entire care systems.

Identifying designs and improvement
practices that are adaptable and scaleable to diverse care settings, delivery
systems, and patient populations; identifying forces affecting the spread and
sustainability of these designs and practices.

Developing, assessing, testing, and
disseminating methods, measures, data and tools needed by decision makers to
track, report and improve cost and efficiency as well as quality -- to include
special emphases on such issues within and across sites of care.

Understanding and projecting
effects of policy, payment, insurance, organizational and market conditions
and changes on provider and other healthcare sector participants' behavior and
on healthcare value, efficiency and quality – including methodological advances
in risk adjustment for payment purposes, organizational, delivery system, and
community wide strategies to improve value and efficiency.

Providing evidence of effects of
Federal and State regulatory and legal changes on the organization, financing,
accessibility, delivery, quality and cost of health care, to include the
effects of Medicare, Medicaid, and SCHIP benefit provisions.

Assessing effects of consumer
incentives on consumer behavior, to include methods of increasing prevention
and wellness behaviors, factors consumers consider when choosing health plans,
and the effects of public reporting strategies and diverse purchaser strategies
to improve value.

Assessing (from multiple
stakeholders' points of view) the organizational and societal costs and the
rates of return for direct investments required to achieve more value in health
care.

Addressing related and similar
issues in the context of safety net institutions and AHRQ's priority
populations.

Scope of this FOA:

The common characteristic of the small research grant is provision of
limited funding for a short period of time. Some examples of the types of
projects that R03 research involves include the following:

Pilot or feasibility studies

Secondary analysis of existing data

Small, self-contained research projects

Development of research methodology

Development of new research technology

The AHRQ R03 small grant is a mechanism for supporting discrete,
well-defined projects that realistically can be completed within two years and
that require limited levels of funding. Because the research plan is
restricted to 15 pages, an R03 grant application may not have the same level of
detail as that found in an R01 application. Accordingly, appropriate
justification for the proposed work can be provided through literature
citations, data from other sources, or from investigator-generated data.
Preliminary data are not required, particularly in applications proposing pilot
or feasibility studies.

Applicants are strongly encouraged to address health services research
issues critical to AHRQ priority populations, including: individuals living in
inner city and rural (including frontier) areas; low-income and minority
groups; women, children, and the elderly; and individuals with special health
care needs, including those with disabilities and those who need chronic or
end-of-life health care.

This Funding Opportunity Announcement (FOA) invites applications for small
research (R03) projects. The individual researcher sponsored by each
organizational awardee will be solely responsible for planning, directing, and
executing his or her proposed projects.

AHRQ is not using the Modular Grant Application and Award Process.
Applications submitted in modular format will not be reviewed.

2. Funds Available

Because the nature and scope of the proposed research will vary from
application to application, it is anticipated that the size and duration of
each award will also vary. Although the financial plans of the AHRQ
provide support for this program, awards pursuant to this funding opportunity
are contingent upon the availability of funds and the receipt of a sufficient
number of meritorious applications.

The budget limit on small project grant applications is $100,000 total
costs (i.e., direct costs plus Facilities and Administrative (F&A) costs)
for the entire project period. A project period of up to two years may be
requested. Applications requesting more than $100,000 total costs or
longer than 24 months of support will not be reviewed.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your domestic organization is a:

Public or non-profit private institution, such as a university,
college, or a faith-based or community-based organization;

Units of local or State government;

Eligible agencies of the Federal government;

Indian/Native American Tribal Government (Federally Recognized);

Indian/Native American Tribal Government (Other than Federally
Recognized);

Indian/Native American Tribally Designated Organizations.

For the purpose of this FOA, AHRQ will make grants only to non-profit
organizations. For-profit organizations may participate in projects as
members of consortia or as subcontractors only. Because
the purpose of this program is to improve healthcare in the United States, foreign institutions may participate in projects as members of consortia or as subcontractors
only. Applications submitted by for-profit organizations and foreign
institutions will not be reviewed. Organizations described in section
501(c) 4 of the Internal Revenue Code that engage in lobbying are not eligible.

1.B. Eligible Individuals

Any individual with the skills, knowledge,
and resources necessary to carry out the proposed research is invited to work
with his/her institution to develop an application for support. Individuals
from underrepresented racial and ethnic groups as well as individuals with
disabilities are always encouraged to apply as Project Director/Principal
Investigator (PD/PI) for AHRQ programs. AHRQ also encourages new investigators to apply as PD/PIs.

2. Cost Sharing or Matching

AHRQ does not require cost sharing for applications submitted in response to
this FOA.

3. Other-Special Eligibility Criteria

Number of Applications: Applicants may submit more than one application, provided each
application is scientifically distinct. However, AHRQ will not accept
similar grant applications with essentially the same research focus from the
same applicant organization.

Resubmissions: Applicants may submit one resubmission
application, but such application must include an Introduction addressing
issues raised in the previous critique (Summary Statement).

Renewals: Applicants may not submit a renewal
application.

Projects must be self-contained. They may be conceptually linked to
future or past projects, but must contain all the elements of a stand-alone
effort that can be reviewed and evaluated on its own for both scientific merit and
budget.

The request may not be used to supplement currently supported projects,
provide interim support for projects under review by the PHS, or obtain funding
as a competing continuation of a small grant. Requests for support for
thesis or dissertation research will not be considered under this small grant
program. Applications to support dissertations should be submitted for
consideration under the AHRQ Small Grant Program for Health Services
Dissertation Research.

The individual designated as the PD/PI on the application must also
be registered in the NIH eRA Commons. It is not necessary for PD/PIs to
register with Grants.gov.

The PD/PI must hold a PD/PI account in the Commons and must be
affiliated with the applicant organization. This account cannot have any
other role attached to it other than the PD/PI. An applicant should not share a Commons account for both
an Authorized Organization Representative/Signing Official (AOR/SO) role
and a PD/PI role; however, if he or she has both a PD/PI role and an
Internet Assisted Review (IAR) role, both roles should exist under one
Commons account.

This registration/affiliation must be done by the Authorized
Organization Representative/Signing Official (AOR/SO) or their designee
who is already registered in the Commons.

Both the PD/PI and Authorized Organization Representative/Signing
Official (AOR/SO) need separate accounts in the NIH eRA Commons since both are
authorized to view the application image.

Note: The
registration process is not sequential. Applicants should begin the
registration processes for both Grants.gov and eRA Commons as soon as their
organization has obtained a DUNS number. Only one DUNS number is required
and the same DUNS number must be referenced when completing Grants.gov registration, eRA Commons registration and the SF424 (R&R) forms.

1. Request Application Information

Applicants must download the SF424 (R&R)
application forms and SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be
used. You will not be able to use any other SF424 (R&R) forms (e.g., sample
forms, forms from another FOA), although some of the “Attachment” files may be
useable for more than one FOA.

The SF424 (R&R) Application Guide is critical to submitting a
complete and accurate application to AHRQ. There are fields within the SF424
(R&R) application components that, although not marked as mandatory, are
required by AHRQ (e.g., the “Credential” log-in field of the
“Research & Related Senior/Key Person Profile” component must contain the
PD/PI’s assigned eRA Commons User ID).
Agency-specific instructions for such fields are clearly identified in the
Application Guide. For additional information, see “Tips and Tools for
Navigating Electronic Submission” on the front page of “Electronic Submission of Grant
Applications.”

The SF424 (R&R) application is comprised of data arranged in
separate components. Some components are required, others are optional. The
forms package associated with this FOA in Grants.gov/APPLYwill include all
applicable components, required and optional. A completed application in
response to this FOA will include the following components:

To submit an application in response to this FOA, applicants should access this
FOA via http://www.grants.gov/Apply and follow steps 1-4. Note: Applications must only be submitted
electronically. PAPER
APPLICATIONS WILL NOT BE ACCEPTED. All
attachments must be provided to AHRQ in PDF format, filenames must be included
with no spaces or special characters, and a pdf extension must be used.

3.C. Application
Processing

3.C.1
Submitting On-Time

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the
applicant institution/organization) on the application due date(s). (See Section IV.3.A. for all
dates.) If
an application is not submitted by the due date(s) and time, the application
may be delayed in the review process or not reviewed. All applications must
meet the following criteria to be considered “on-time”:

All registrations
must be complete prior to the submission deadline

The application must
receive a Grants.gov tracking number and timestamp (or eRA help desk ticket
confirming a system issue preventing submission) by 5:00 p.m. local time on the
submission deadline date.

Any system identified
errors/warnings must be corrected and the submission process completed within
the “error correction window.”

Submission to Grants.gov is not the last step – applicants must follow their application through to the eRA
Commons to check for errors and warnings and view their assembled application!

3.C.2 Two Day
Window to Correct eRA Identified Errors/Warnings

IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond.
As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See
NOT-OD-10-123.

Once an
application package has been successfully submitted through Grants.gov,NIH provides
applicants a two day error correction window to correct any eRA
identified errors or warnings before a final assembled application is created
in the eRA Commons. The standard error correction window is two (2) business
days, beginning the day after the submission deadline and excluding weekends
and standard federal holidays. All errors must be corrected to successfully
complete the submission process. Warnings will not prevent the application
from completing the submission process.

Please note
that the following caveats apply:

Initial
application submission must be “on-time.”

The
AOR/institutions is expected to enforce that application changes made within
the error correction window are restricted to those necessary to address
system-identified errors/warnings. NIH may reject any application that
includes additional changes.

Proof of
“on-time” submission (e.g., Grants.gov timestamp and tracking number) and
description of all changes made within the window must be documented in the PHS
398 Cover Letter component of the application.

3.C.3 Viewing an Application in the eRA
Commons

Once
any eRA identified errors have been addressed and the assembled application has
been created in the eRA Commons, the PD/PI and the Authorized Organization
Representative/Signing Official (AOR/SO) have two weekdays (Monday – Friday,
excluding Federal holidays) to view the assembled application before it automatically moves forward to NIH for further
processing.

If everything is acceptable, no further
action is necessary. The
application will automatically move forward to the Division of Receipt and
Referral in the Center for Scientific Review for processing after two weekdays, excluding Federal holidays.

Prior
to the submission deadline, the AOR/SO can “Reject” the assembled application
and submit a changed/corrected application within the two-day viewing window.
This option should be used if it is determined that some part of the
application was lost or did not transfer correctly during the submission
process, the AOR/SO will have the option to “Reject” the application and submit
a Changed/Corrected application. In these cases, please contact the eRA Help Desk to
ensure that the issues are addressed and corrected. Once rejected, applicants
should follow the instructions for correcting errors in the SF 424 (R&R)
application guide, including the requirement for cover letters on late
applications. The “Reject”
feature should also be used if you determine that warnings are applicable to
your application and need to be addressed now. Remember, warnings do not stop
further application processing. If an application submission results in
warnings (but no errors), it will automatically move forward after two weekdays
if no action is taken. Some warnings may need to be addressed later in the
process.

f
the two-day window falls after the submission deadline, the AOR/SO will have
the option to “Reject” the application if, due to an eRA Commons or Grants.gov system issue, the application does not correctly reflect the submitted application
package (e.g., some part of the application was lost or didn’t transfer
correctly during the submission process). The AOR/SO should first contact the eRA Commons Helpdesk to confirm the system error, document the issue, and
determine the best course of action. NIH will not penalize the applicant for an
eRA Commons or Grants.gov system issue.

If
the AOR/SO chooses to “Reject” the image after the submission deadline for a
reason other than an eRA Commons or Grants.gov system failure, a
changed/corrected application still can be submitted, but it will be subject to
the NIH
late policy guidelines and may not be accepted. The reason for this delay should be
explained in the cover letter attachment.

Both
the AOR/SO and PD/PI will receive e-mail notifications when the application is
rejected or the application automatically moves forward in the process after
two weekdays.

Upon
receipt, applications will be evaluated for completeness by the Center for Scientific Review,
NIH, and AHRQ. Incomplete applications will
not be reviewed.

There will be an
acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR/SO
receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific
Review Group is also in the Commons.

Note: Since email can be unreliable, it is the
responsibility of the applicant to check periodically on their application status
in the Commons.

AHRQ will not accept any application in response to
this FOA that is essentially the same as one currently pending initial merit
review unless the applicant withdraws the pending application. AHRQ will not
accept any application that is essentially the same as one already reviewed.
However, AHRQ will accept a resubmission application, but such application must
include an Introduction addressing the critique from the previous review.

Institutional Review Board (IRB) approval of human subjects is not
required prior to peer review of an AHRQ application. The “AHRQ Revised Policy
for IRB Review of Human Subjects Protocols in Grant Applications” was published
in the NIH Guide on September 27, 2000. (https://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html).

Use of CMS Data

Purchase of Centers for Medicare and Medicaid Services (CMS) public-use
data, if required, should be discussed in the application narrative and
included in the budget. Projects will ordinarily not use CMS (Medicare or
Medicaid) data involving individual identifiers. However, for applications that
propose to use Medicare or Medicaid data that are individually identifiable,
applicants should state explicitly in the “Research Design and Methods” section
of the Research Plan (form 398) the specific files, time periods, and cohorts
proposed for the research. In consultation with CMS, previously called Health
Care Financing Administration (HCFA), AHRQ will use this information to develop
a cost estimate for obtaining the data. This estimate will be included in the
estimated total cost of the grant at the time funding decisions are made.

Applicants should be aware that for individually identifiable Medicare
and Medicaid data, Principal Investigators and their grantee institutions will
be required to enter into a Data Use Agreement (DUA) with CMS to protect the
confidentiality of data in accordance with AHRQ's confidentiality statute, 42 USC
299c-3(c), the Privacy rules at 45 CFR Parts 160 and 164, if applicable, and
standards set out in OMB Circular A-130, Appendix III–Security of Federal
Automated Information Systems. The use of the data will be restricted to the
purposes and time period specified in the DUA. At the end of this time period,
the grantee will be required to return the data to CMS or certify that the data
have been destroyed.

Unless AHRQ is able to negotiate exceptional arrangements included in
the DUA is the requirement that the User agrees to submit to CMS, a copy of all
findings within 30 days of making such findings, for the sole purpose of
assuring CMS that data confidentiality is maintained. The user further agrees
not to submit these findings to any third party (including but not limited to
any manuscript to be submitted for publication) until receiving CMS's approval
to do so.

In developing research plans, applicants should allow time for refining,
obtaining approval, and processing of their CMS data requests. Requests may
take 6 months from the time they are submitted to complete. Applications
proposing to contact beneficiaries or their providers require the approval of
the CMS Director and may require meeting(s) with CMS staff.

CMS data are provided on IBM mainframe tapes using the record and data
formats commonly employed on these computers. Applicants should either have the
capability to process these tapes and formats or plan to make arrangements to
securely convert them to other media and formats.

Questions regarding CMS data should be directed to the AHRQ program
official listed under INQUIRIES.

To avoid double counting, applicants should not include the cost of the
CMS data in the budget. Small research grant applicants should be aware
that the costs of the grant, including the cost of CMS data, cannot exceed
$100,000 total costs. In the event the total costs of the project plus the
cost of CMS data is greater than $100,000, the budget for the project will be
adjusted so that the total costs awarded to the recipient plus the CMS data
costs do not exceed $100,000.

4. Intergovernmental Review

This program is not subject to the intergovernmental review requirements of
Executive Order 12372 or Health Systems Agency review.

5. Funding Restrictions

For efficient grant administration, AHRQ grant administration procedures will
be used and conducted in accordance with the terms and conditions, cost
principles, and other considerations described in the HHS Grants Policy Statement. The Grants Policy Statement can be found at http://www.ahrq.gov/fund/hhspolicy.htm

Pre-award costs are allowable. A grantee may, at its own risk and
without AHRQ prior approval, incur obligations and expenditures to cover costs
up to 90 days before the beginning date of the initial budget period of a new
award if such costs are necessary to conduct the project and would be allowable
under the grant, if awarded, without AHRQ prior approval. If specific
expenditures would otherwise require prior approval, the grantee must obtain
AHRQ approval before incurring the cost. AHRQ prior approval is required for
any costs to be incurred more than 90 days before the beginning date of the
initial budget period of a new award.

The incurrence of pre-award costs in
anticipation of a competing or non-competing award imposes no obligation on
AHRQ either to make the award or to increase the amount of the approved budget
if an award is made for less than the amount anticipated and is inadequate to
cover the pre-award costs incurred. AHRQ expects the grantee to be fully aware
that pre-award costs result in borrowing against future support and that such
borrowing must not impair the grantee's ability to accomplish the project
objectives in the approved time frame or in any way adversely affect the
conduct of the project.

The applicant organization must include its DUNS number in its
Organization Profile in the eRA Commons. This DUNS number must match the DUNS
number provided at CCR registration with Grants.gov. For additional information, see “Frequently Asked Questions –
Application Guide, Electronic
Submission of Grant Applications.”

All application instructions outlined in the SF424 (R&R) Application
Guide are to be followed, incorporating "Just-in-Time" information
concepts, and with the following additional requirements:

Introduction (required for a resubmission or revision application)
is limited to 1 page.

Specific Aims is limited to 1 page.

Research Strategy, including tables, graphs, figures, diagrams, and
charts, is limited to 15 pages.

Competing renewal (formerly “competing continuation”) applications will
not be accepted for the R03 grant mechanism. Small grant support may not be
used for thesis or dissertation research. Up to one resubmission (formerly
“revisions/amendments") of a previously reviewed small grant application
may be submitted.

Budget
Component

R03 applications will use the Research & Related budget components,
with a maximum allowable request of up to $100,000
in total costs for up to two years. Provide a narrative justification for
each proposed personnel position, including role and proposed level of effort.

Specific Instructions for Modular Grant applications: AHRQ is not using the Modular Grant Application and Award Process.
Applicants for funding from AHRQ should ignore application instructions
concerning the Modular Grant Application and Award Process, and prepare
applications using instructions for the Research and Related Budget Components
of the SF 424 (R&R). Applications submitted in the Modular format will not be
reviewed.

Appendix
Materials (New and Resubmission Applications)

R03 Appendix materials may include graphic images, micrographs, etc.
provided that the image is contained within the 15 page limit of the Research Strategy.
No images may be included in the Appendix that are not also represented
within the Research Strategy. No publications or other printed material, with
the exception of pre-printed questionnaires or surveys, may be included in the
Appendix.

Do not use the Appendix to circumvent the page limitations of the
Research Strategy. An application that does not observe these limitations may
be delayed in the review process.

Priority
Populations

The Healthcare Research and Quality Act of 1999, in amending the PHS
Act, directed AHRQ, in carrying out its mission, to conduct and support
research and evaluations, and to support demonstration projects, with respect
to the delivery of health care in inner-city and rural areas (including
frontier areas); and health care for priority populations, which include low
income groups; minority groups; women; children; the elderly; and individuals
with special health care needs, including individuals with disabilities and
individuals who need chronic care or end-of-life health care. This
authority is also found at 42 USC 299. To implement this statutory mandate,
AHRQ published a Notice in the NIH Guide on February 28, 2003, establishing a
new Agency policy on the Inclusion of Priority Populations in health services
research (see https://grants.nih.gov/grants/guide/notice-files/NOT-HS-03-010.html).
Applicants under this FOA should consider and discuss including priority
populations in the research design as specified in this Notice.

Publication
Transmittal: General AHRQ Requirements

In keeping with the Agency's efforts to translate the results of
AHRQ-funded research into practice and policy, grantees are to inform the AHRQ
Office of Communications and Knowledge Transfer (OCKT) when articles from their
AHRQ supported activities are accepted for publication in the professional
literature. Grantees should also discuss any ideas about other dissemination
and marketing efforts with OCKT staff. The goal is to ensure that efforts to disseminate
research findings are coordinated with other Agency activities to maximize
awareness and application of the research by potential users, including
clinicians, patients, health care systems and purchasers and policymakers. This
is critical when outreach to the general and trade press is involved.
Accordingly, contact with the media will take place with close coordination
between OCKT and the press offices of the grantee's institutions. In cases when
products are created (such as annual or final reports, Web-based tools,
CD-ROMs), grantees will be asked to submit to OCKT a brief plan describing how
the product will be publicized. An OCKT staff person will be assigned to each
product and will coordinate the implementation of the plan, especially issues
related to printing and electronic dissemination, and outreach to the media.

Assessment
of AHRQ Grant Programs

In carrying out its stewardship of research programs, AHRQ may request
information essential to an assessment of the effectiveness of Agency research
programs. Accordingly, grant recipients are hereby notified that they may be
contacted after the completion of awards for periodic updates on publications
resulting from AHRQ grant awards, and other information helpful in evaluating
the impact of AHRQ-sponsored research.

AHRQ expects grant recipients to keep the Agency informed of
publications as well as the known uses and impact of their Agency-sponsored
research. Applicants are to agree to notify AHRQ immediately when a manuscript
based on research supported by the grant is accepted for publication, and to
provide the expected date of publication as soon as it is known, regardless of
whether or not the grant award is still active.

HCUPS & MEPS

Applicants are encouraged to make use of AHRQ’S Healthcare Cost and
Utilization Project (HCUP) or the Medical Expenditure Panel Survey
(MEPS). HCUP is a family of health care databases and related software
tools and products developed through a Federal-State-Industry partnership.
HCUP inpatient databases bring together the data collection efforts of
State data organizations, hospital associations, private data organizations,
and the Federal government to create a national information resource of
patient-level health care data. HCUP databases provide data beginning in
1988 and contain encounter-level information for all payers compiled in a
uniform format with privacy protections in place. HCUP databases
include: the Nationwide Inpatient Sample (NIS) with inpatient data from a
national sample of approximately 1,000 hospitals, the Kids’ Inpatient Database
(KID) with a nationwide sample of pediatric inpatient discharges, the State
Inpatient Databases (SID) with the universe of inpatient discharge abstracts
from participating states, the State Ambulatory Surgery Databases (SASD) with
data from ambulatory care encounters from hospital-affiliated and sometimes
freestanding ambulatory surgery sites from participating states, and the State
Emergency Department Databases (SEDD) with data from emergency department
encounters from hospital-affiliated emergency departments from participating
states. More information on HCUP can be found at http://www.hcup-us.ahrq.gov/home.jsp.

MEPS is conducted to provide nationally representative estimates of
health care use, expenditures, sources of payment, and insurance coverage for
the U.S. civilian, noninstitutionalized population. MEPS is comprised of
three component surveys: the Household Component (HC), the Medical Provider
Component (MPC), and the Insurance Component (IC). The Household Component is
the core survey, and it forms the basis for the MPC sample and part of the IC
sample. The MEPS IC collects data on health insurance plans obtained
through employers and unions, including the number and types of private
insurance plans offered, employer characteristics, premiums, and contributions
by employers and employees. More information on MEPS is available at http://www.meps.ahrq.gov.

This does not preclude the use of secondary data sources or primary data
collection.

Health Literacy

AHRQ encourages applicants to write Informed
Consent (IC) and HIPAA Authorization documents for research to be
understandable to all potential research participants, including those with low
levels of literacy and limited English proficiency. AHRQ recommends that IC
and Authorization documents be written in accordance with health literacy
principles, and that IC and Authorization documents be available in multiple
languages if potential research participants include individuals with limited
English proficiency. AHRQ also recommends adopting a process to verify
potential research participants’ understanding.

IC documents must provide information in
language understandable to potential participants (45 CFR 46.116).
For covered entities under the Privacy Rule, authorization documents must
include core elements and required statements in (45 CFR 164.508(c) and
must be written in plain language. The AHRQ Informed Consent and Authorization
Toolkit for Minimal Risk Research (http://www.ahrq.gov/fund/informedconsent/)
provides sample forms and guidance on adapting them, and also describes an
appropriate process for obtaining informed consent and authorization.

Consumer Products

All consumer products produced under an
AHRQ-funded grant should be appropriate for the target audience. This includes
individuals from diverse cultural, language, and literacy backgrounds.
Audience testing should be part of the development process. AHRQ’s Talking
Quality website (http://www.talkingquality.gov/)
and AHRQ’s guide and checklist for developers and purchasers of health
information (IT) that is designed to be accessed and used by consumers (http://healthit.ahrq.gov and select Health
IT Tools) are resources applicants can use to ensure appropriateness of
consumer products.

Plan for Sharing Research Data

Not Applicable

Sharing Research Resources

Not Applicable

Section V. Application Review Information

1. Criteria

Administrative Criteria: Upon receipt, applications will be reviewed by
AHRQ for completeness and responsiveness.

Merit Review Criteria are described below. Only the review criteria
described below will be considered in the review process.

2. Review and Selection Process

Review Process

Applications that are complete and responsive to the FOA will be
evaluated for scientific and technical merit by an appropriate peer review
group convened in accordance with standard AHRQ peer review procedures that are
described in 42 CFR Part 67, Subpart A. Incomplete and/or non-responsive
applications or applications not following instructions given in this FOA will not
be reviewed. .

As part of the initial merit review, all applications
will:

Undergo a selection process in which only those applications deemed
to have the highest scientific merit will be discussed and assigned a
priority score.

Receive a written critique.

The
mission of AHRQ is to
improve the quality, safety, efficiency, and effectiveness of health care for
all Americans. As part of this
mission, applications submitted to AHRQ to support health services research are
evaluated for scientific and technical merit through the AHRQ peer review
system.

The R03 small grant mechanism at AHRQ supports discrete, well-defined
projects that realistically can be completed in two years. Because the
research plan is restricted to 15 pages, an R03 grant application will not have
the same level of detail or extensive discussion found in an R01
application. Accordingly, reviewers will evaluate the conceptual framework
and general approach to the problem, placing less emphasis on methodological
details and certain indicators traditionally used in evaluating the scientific
merit of R01 applications including supportive preliminary data. Appropriate
justification for the proposed work can be provided through literature
citations, data from other sources, or from investigator-generated
data. Preliminary data are not required, particularly in applications
proposing pilot or feasibility studies.

Overall Impact. Reviewers will provide an overall
impact/priority score to reflect their assessment of the likelihood for the
project to exert a sustained, powerful influence on the research field(s)
involved, in consideration of the following five scored review criteria, and
additional review criteria (as applicable for the project proposed).

Scored Review Criteria. Reviewers
will consider each of the five review criteria below in the determination of
scientific and technical merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact. For example, a project that by its nature
is not innovative may be essential to advance a field.

Significance: Does this study address an important scientific area or critical
barrier to progress in the field of health services research? If the aims of
the application are achieved, how will scientific knowledge or clinical
practice be advanced? What will be the effect of this study on the concepts,
methods, technologies, treatments, services, or preventative interventions that
drive health services research?

Investigators: Are the investigators appropriately trained
and well suited to carry out this work? Is the work proposed appropriate to the
experience level of the PD/PI and other researchers? Does the investigative
team bring complementary and integrated expertise to the project (if
applicable)?

Innovation: Is the project original and innovative? For example: Does the project
challenge and seek to shift existing research or clinical practice paradigms;
address an innovative hypothesis or critical barrier to progress in the field
of health services research? Does the project develop or employ novel concepts,
approaches, methodologies, interventions, tools, or technologies for the
proposed area of study?

Approach: Are the overall strategy, methodology, and
analyses well reasoned and appropriate to accomplish the specific aims of the
project? Are potential problems, alternative strategies, and benchmarks for
success presented? If the project is in the early stages of development, will
the strategy establish feasibility and will any particularly risky aspects be
managed? If the project involves human subjects research are the plans for: 1)
protection of human subjects from research risks and, 2) inclusion of AHRQ
priority populations, justified in terms of the scientific goals and proposed research
strategy?

Environment: Does the scientific environment in which the work will be done
contribute to the probability of success? Are the institutional support,
equipment, and other physical resources available to the investigators adequate
for the proposed project? Will the proposed studies benefit from unique
features of the environment, or subject populations, or employ useful
collaborative arrangements

2.A. Additional Review Criteria:

As applicable for the project proposed,
reviewers will consider the following additional items in the determination
of scientific and technical merit, but will not give separate scores for these
items.

Protection of Human Subjects from Research Risk: For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria
for one or more of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate: 1) the justification for the exemption,
2) human subjects involvement and characteristics, and 3) sources of materials.

Inclusion: Adequacy of plans to address the needs of
both genders, racial and ethnic minorities (and subgroups). Adequacy of
attention to AHRQ priority populations (see discussion on Priority Populations
in the section on Special Requirements, above, and Inclusion Criteria included
in section VIII of Required Federal Citations, below.)

Budget: Is the
proposed budget reasonable and is the requested period of support appropriate
in relation to the proposed research?

2.B. Additional Review Considerations

Not Applicable

2.C. Sharing Research Data

Data Confidentiality

Pursuant to section 934(c) of the (PHS) Act (42 USC 299c-3(c)),
information obtained in the course of any AHRQ supported-study that identifies
an individual or entity must be treated as confidential in accordance with any
explicit or implicit promises made regarding the possible uses and disclosures
of such data. There are now civil monetary penalties for violation of this
confidentiality statute [42 U.S.C.299c-3(d)). In the Human Subjects section of
the application, applicants must describe procedures for ensuring the
confidentiality of the identifying information to be collected. The description
of the procedures should include a discussion of who will be permitted access
to this information, both raw data and machine readable files, and how personal
identifiers and other identifying or identifiable data will be restricted and
safeguarded. Identifiable patient health information collected by grantees
under this RFA will also be obtained and managed in accordance with 42 CFR
Parts 160 and 164, the Federal Privacy Rule developed by the Department of
Health and Human Services (DHHS) pursuant to the Health Insurance Portability
and Accountability Act of 1996 (HIPAA). These regulations serve to limit the
disclosure of personally identifiable patient information by covered entities
and define when and how such information can be disclosed e.g., to researchers.
Thus, health care plans, for example, ordinarily will require either patient authorization
of disclosures of identifiable information to be made to researchers or waivers
of such authorizations obtained from an IRB or Privacy Board (defined in the
regulations) which will involve review to ensure that identifiable health
information will be appropriately safeguarded by the investigators. The DHHS
Office of Civil Rights is the enforcement body for this regulation. Additional
information about the regulations, their implementation, and alternative
methods of permissible disclosures to researchers (limited data sets with data
use agreements, de-identified data sets, data about deceased persons, and data
use to develop protocols) can be obtained from: http://www.aspe.hhs.gov/admnsimp/ or http://www.hhs.gov/ocr/hipaa/.

The awardee should ensure that computer systems containing confidential
data have a level and scope of security that equals or exceeds that established
by the HIPAA Security Rules if applicable (see HIPAA websites in prior
paragraph) and that established by the Office of Management and Budget (OMB) in
OMB Circular No. A-130, Appendix III - Security of Federal Automated
Information Systems. The National Institute of Standards and Technology (NIST)
has published several implementation guides for this circular. They are: An
Introduction to Computer Security: The NIST Handbook; Generally Accepted
Principals and Practices for Securing Information Technology Systems; and Guide
for Developing Security Plans for Information Technology Systems. The circular
and guides are available on the web at http://csrc.nist.gov/publications/nistpubs/800-12/.
The applicability and intended means of applying these confidentiality and
security standards to subcontractors and vendors, if any, should be addressed
in the application.

2.D. Sharing Research Resources

Rights in Data

AHRQ grantees may copyright, unless otherwise provided in grant awards,
or seek patents, as appropriate, for final and interim products and materials
including, but not limited to, methodological tools, measures, software with
documentation, literature searches, and analyses, which are developed in whole
or in part with AHRQ funds. Such copyrights and patents are subject to a
worldwide irrevocable AHRQ license to use and permit others to use these
products and materials for government purposes. In accordance with its
legislative dissemination mandate, AHRQ purposes may include, subject to
statutory confidentiality protections, making project materials, databases,
results, and algorithms available for verification or replication by other
researchers; and subject to AHRQ budget constraints, final products may be made
available to the health care community and the public by AHRQ or its agents, if
such distribution would significantly increase access to a product and thereby
produce substantial or valuable public health benefits. Ordinarily, to
accomplish distribution, AHRQ publicizes research findings but relies on
grantees to publish research results in peer-reviewed journals and to market
grant-supported products. AHRQ's Office of Communications and Knowledge
Transfer (OCKT) wishes to be consulted in advance of publication in order to
coordinate announcements of new AHRQ-supported research results with other AHRQ
dissemination activities. Important legal rights and requirements applicable to
AHRQ grantees are set out or referenced in the AHRQ's grants regulation at 42
CFR Part 67, Subpart A (Available in libraries and from the GPO's website http://www.gpoaccess.gov/cfr/index.html).

Selection Process

Applications submitted in response to this funding opportunity will compete
for available funds with all other recommended R03 applications. The following
will be considered in making funding decisions:

Scientific merit of the proposed project as determined by peer
review

Availability of funds

Responsiveness to goals and objectives of the FOA.

Relevance and fit within AHRQ portfolio priorities, as well as
overall programmatic balance

After the peer review of the application is
completed, the PD/PI will be able to access his or her Summary Statement
(written critique) via the NIH eRA Commons

If the application is under consideration for funding, AHRQ will request "Just-In-Time" information from the applicant. Just-In-Time
information generally consists of information on other support, any additional
information necessary to address administrative issues, and certification of
IRB approval of the project's proposed use of human subjects. For
details, applicants may refer to the "AHRQ Revised Policy for
Institutional Review Board (IRB) Review of Human Subjects Protocols in Grant
Applications" (https://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html).

Once all administrative and programmatic issues have been resolved, a formal
notification in the form of the Notice of Award (NoA) will be generated
via email notification from the awarding component to the grantee business
official at the applicant organization. The NoA signed by the AHRQ grants management officer is the authorizing document.

Selection of an application for award is not an authorization to begin
performance. Any costs incurred before receipt of the NoA are at the
recipient’s risk. These costs may be reimbursed only to the extent considered
allowable pre-award costs. See also Section IV.5.,
“Funding Restrictions.”

As necessary, Terms and Conditions will be incorporated into the award
statement and will be provided to the Principal Investigator as well as to the
appropriate institutional official, at the time of award.

The progress report is to include descriptive and evaluative comments on
both completed activities and plans for the remainder of that year, including
any changes foreseen in the future. At a minimum, the reports will include
descriptive comments on: progress to date measured against project aims; methodological
changes implemented; key preliminary findings; significant problems and
resolutions; inclusion of priority populations; and project related
publications, presentations, and dissemination activities. AHRQ will
provide the timetable for these progress reports.

Financial Status Reports (FSRs; SF 269) are required annually by AHRQ
for ALL grant programs. This report must be submitted for each budget
period no later than 90 days after the close of the budget period. A hard
copy of the report should be submitted to the assigned grants management
specialist.

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity and
welcome the opportunity to answer questions from potential applicants.
Inquiries may fall into three areas: scientific/research, peer review, and
financial or grants management issues:

1. Scientific/Research Contacts:

AHRQ welcomes the opportunity to clarify any issues or questions from potential
applicants who have read the FOA. Written and telephone inquiries
concerning this FOA are encouraged.

Women and members of minority groups are to be included in all AHRQ-supported
research projects involving human subjects, unless a clear and compelling
rationale and justification are provided that inclusion is inappropriate: e.g.,
because of the lack of connection between the study and the health of women or
particular minorities.

Investigators may obtain copies from the above sources or from the AHRQ
Publications Clearinghouse, listed under INQUIRIES, or from the NIH Guide Web
site https://grants.nih.gov/grants/guide/index.html.
AHRQ Program staff may also provide additional information concerning these
policies (see INQUIRIES).

Human Subjects Protection:

Federal regulations 45 CFR 46 require that applications and proposals
involving human subjects research must be evaluated in accordance with those
regulations, with reference to the risks to the subjects, the adequacy of
protection against these risks, the potential benefits of the research to the
subjects and others, and the importance of the knowledge gained or to be
gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

The Department of Health and Human Services (DHHS) "Standards for
Privacy of Individually Identifiable Health Information", regulation was
mandated by the Health Insurance Portability and Accountability Act (HIPAA) of
1996 which governs the protection of individually identifiable health
information. It is administered and enforced by the DHHS Office for Civil Rights
(OCR). Compliance with the Privacy Rule for those classified under the Rule as
"covered entities". Decisions about applicability and
implementation of the Privacy Rule reside with covered entities. The OCR
website (http://www.hhs.gov/ocr/)
provides information on the Privacy Rule, including a complete Regulation Text
and a set of decision tools that may be used to determine whether a researcher
is a staff of a covered entity. Project Officers will assist grantees in
resolving questions about the applicability of HIPAA requirements.

Access to Research Data through the Freedom of Information Act:

The OMB Circular A-110 has been revised to provide access to research
data developed with Federal support through the Freedom of Information Act
(FOIA) in certain circumstances. Data that are (1) first produced in a project
that is supported in whole or in part with Federal funds and (2) cited publicly
and officially by a Federal agency in support of an action that has the force
and effect of law (i.e., a regulation) may be accessed through FOIA. If no
Federal act is taken, having the force and effect of law, in reliance upon an
AHRQ-supported research project, the underlying data are not subject to this
disclosure requirement. Furthermore, even if a Federal regulatory action is
taken in reliance on AHRQ-supported research data under FOIA, 5 USC 552(b),
disclosure of confidential identifiable data from such study, statutorily
protected under 42 U.S.C. Section 299c-3(c), is exempted from disclosure under
"the (b)(3) exemption” in FOIA. It is important for applicants to
understand the scope of this requirement and its limited potential impact on
data collected with AHRQ support. Proprietary data might also be exempted from FOIA
disclosure requirements under "the (b)(4) exemption", for example, if
it constitutes trade secrets or commercial information. NIH has provided
general related guidance at https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm which does not include discussion of the exception applicable to confidential
identifiable data collected under AHRQ's authorities.

Should applicants wish to place data collected under this FOA in a
public archive, which can provide protections for the data (e.g., as required
by the confidentiality statute applicable to AHRQ supported projects, 42 U.S.C.
299c-3(c)) and manage the distribution of non-identifiable data for an
indefinite period of time, they may. The application should include a
description of any archiving plan in the study design and include information
about this in the budget justification section of the application. In addition,
applicants should consider how to structure informed consent statements or
other human subject protection procedures to permit or restrict disclosures of
identifiable data, as warranted.

Healthy People 2010:

The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2010,"
a PHS-led national activity for setting health improvement priorities for the United States. AHRQ encourages applicants to submit grant applications with relevance to
the specific objectives of this initiative. Potential applicants may obtain a
copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:

This program is described in the Catalog of
Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive
Order 12372 or Health Systems Agency review. Awards are made under the
authorization of Title IX of the Public Health Service Act (42 USC 299-299c-6),
under Federal Regulations 42 CFR 67 and 45 CFR Parts 74 and 92. All awards are
subject to the terms and conditions, cost principles, and other considerations
described in the PHS Grants Policy Statement. The PHS Grants Policy Statement
can be found at https://grants.nih.gov/grants/policy/gps/index.html.

The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and discourage the use of all tobacco products. In addition, Public
Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain
facilities (or in some cases, any portion of a facility) in which regular or
routine education, library, day care, health care, or early childhood
development services are provided to children. This is consistent with the PHS
mission to protect and advance the physical and mental health of the American
people.